Yale Journal of Health Policy, Law, and Ethics

Current Issue: Volume 20, Issue 2

A Public Option for Employer Health Plans

Allison K. Hoffman, Howell E. Jackson, and Amy B. Monahan

Employer-based private health coverage—long the gold standard of health insurance—is in decline. Employers are increasingly unable to manage the escalating prices that consolidated health care systems can command. In response, over the past two decades, fewer employers are offering health benefits, and, when they do, they cabin their own spending through plans that shift more of the costs to employees to pay on their own. Employers are increasingly exasperated with their secondary role as health benefits companies. This changing picture offers an opportunity to rethink the role that employers play in designing and managing health plans, a role that is often described as an accident of history and that is an impediment to a better health care financing system. Major health reform ideas have tended largely to neglect the employer space (e.g., the Affordable Care Act) or to propose to displace it swiftly and in its entirety (e.g., Medicare for All).

This Article instead proposes a public option targeted at employers, which can both improve job-based health coverage and also build a foundation for a sounder health care financing system overall. In contrast to the more familiar public option proposal, which would offer government sponsored health insurance directly to individuals, our plan creates a public option for employers, who can select a public plan—based on Medicare and altered to meet the needs of working populations— instead of a private health plan for their employees.

We review the policy, regulatory, fiscal, and business arguments in favor of this form of public option, which we argue is less disruptive than a reform like Medicare for All but more impactful than an individual public option. Because employer take-up would be gradual and voluntary, our plan has lower fiscal costs and should face less resistance from employees and vested interests than Medicare for All. Over time, if the plan meets employers’ and employees’ needs, more people would be covered by a public option, moving away from over-reliance on private employer plans and toward something akin to Medicare for Many in a less politically, legally, and fiscally fraught way.

COVID-19 and International Freedom of Movement: A Stranded Human Right?

Fernando Dias Simões

Despite the lack of evidence that travel restrictions are effective, governments confronted with an infectious disease outbreak, especially one involving a poorly understood pathogen, often seek to restrict movement—both internally and across their borders. In response to COVID-19, most countries imposed a ban on foreign travelers, with some States even closing borders to their own nationals and residents or prohibiting them from leaving. While border control is a legitimate prerogative that States can use to assess the health condition of travelers, broader travel restrictions are more complex and raise intricate legal questions. This Article focuses on a specific category of travel restrictions: travel bans. Such measures are blanket prohibitions against crossing international borders applied to all or particular individuals, regardless of their health status. The lawfulness of travel bans depends on several elements. First, one needs to examine the applicable legal framework: the International Health Regulations and human rights treaties. Determining whether travel bans are lawful also depends on a second element: the status of travelers, namely, whether they qualify as nationals, residents, or something else. While all people have the right to leave any country and return to their country, there is no human right to enter a foreign state. After reviewing the legal framework and (available) information on travel bans implemented in response to COVID-19, this Article questions whether the pertinent requirements were respected and examines a few of the more clear-cut cases where travel bans breached the rules and principles that should govern international mobility.

Health AI for Good Rather Than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices

Sara Gerke

Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S. that ensures that such devices are reasonably safe and effective when placed on the market and will remain so throughout their life cycle. I advocate for U.S. Food and Drug Administration (FDA) and congressional actions. I focus on how the FDA could— with additional statutory authority—regulate AI-based medical devices. I show that the FDA incompletely regulates health AI-based products, which may jeopardize patient safety and undermine public trust. For example, the medical device definition is too narrow, and several risky health AI-based products are not subject to FDA regulation. Moreover, I show that most AI-based medical devices available on the U.S. market are 510(k)-cleared. However, the 510(k) pathway raises significant safety and effectiveness concerns. I thus propose a future regulatory framework for premarket review of medical devices, including AI- based ones. Further, I discuss two problems that are related to specific AI-based medical devices, namely opaque (“black-box”) algorithms and adaptive algorithms that can continuously learn, and I make suggestions on how to address them. Finally, I encourage the FDA to broaden its view and consider AI-based medical devices as systems, not just devices, and focus more on the environment in which they are deployed.

Student CommentPaid Donation: Reconciling Altruism and Compensation in Oocyte Transfer

Saylor S. Soinski

In the United States, legislation, case law, and professional guidelines have not kept pace with the rapid proliferation of oocyte transfer—commonly known as “egg donation.” As a result, private agencies have disproportionately shaped the oocyte market. Although the market structure has negative consequences for oocyte providers, prohibiting or limiting compensation will not resolve the potential for exploitation. Oocyte transfer has generally relied on altruistic rhetoric, mobilizing the language of “donation” and painting oocytes as freely given gifts. The focus on altruism is gendered, colored by expectations of ideal womanhood and motherhood, and requires oocyte providers to subordinate their own needs. This Comment proposes a federal regulatory framework that would expand existing FDA and CDC programs to affirm the multiple motivations of oocyte providers and establish uniform safeguards.